Breckenridge Pharmaceutical, Inc. recalls

17 recalls on record · latest: April 21, 2026

Official U.S. recall history for Breckenridge Pharmaceutical, Inc., compiled from official government records.

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Duloxetine Delayed-Release Capsules USP recalled over manufacturing violations

April 21, 2026 · Drug & medication recalls Moderate risk CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recomm…

Duloxetine Delayed-Release Capsules recalled over manufacturing violations

November 24, 2025 · Drug & medication recalls Moderate risk CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recomm…

Duloxetine Delayed-Release Capsules recalled over manufacturing violations

November 24, 2025 · Drug & medication recalls Moderate risk CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recomm…

Duloxetine Delayed-Release Capsules recalled over manufacturing violations

October 9, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limi…

Duloxetine Delayed-Release Capsules recalled over manufacturing violations

August 8, 2025 · Drug & medication recalls Moderate risk CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.

Duloxetine Delayed-Release Capsules recalled over manufacturing violations

July 25, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommende…

Duloxetine Delayed-Release Capsules recalled over manufacturing violations

July 15, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessm…

Duloxetine Delayed-Release Capsules recalled over manufacturing violations

June 30, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommende…

Duloxetine Delayed-Release Capsules USP recalled over manufacturing violations

April 14, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above…

Duloxetine Delayed-Release Capsules USP recalled over manufacturing violations

April 14, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above…

Duloxetine Delayed-Release Capsules recalled over manufacturing violations

March 26, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI…

Duloxetine Delayed-Release Capsules recalled over manufacturing violations

February 28, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommende…

Duloxetine Delayed-Release Capsules recalled over manufacturing violations

February 28, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommende…

Duloxetine Delayed-Release Capsules recalled over manufacturing violations

February 28, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommende…

Duloxetine Delayed-Release Capsules recalled over manufacturing violations

December 6, 2024 · Drug & medication recalls Moderate risk CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommende…

Duloxetine Delayed-Release Capsules recalled over manufacturing violations

December 6, 2024 · Drug & medication recalls Moderate risk CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommende…

Duloxetine Delayed-Release Capsules recalled over manufacturing violations

October 10, 2024 · Drug & medication recalls Moderate risk CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommende…